Interventional Therapy Of Bifurcation Lesions: A New Approach Using Drug-eluting Balloons For The Main Branch And/Or For The Side Branch: The DEBIFU Registry
- Conditions
- Heart disease, coronary artery Stenosis, bifurcation stenosis
- Registration Number
- DRKS00024202
- Lead Sponsor
- Department of Cardiology, Hetzelstift
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
We include male or female patients older than 18 years with a diagnosis of stable angina, silent ischemia or acute coronary syndromes with a de novo coronary bifurcation lesion, defined as stenosis > 50 % determined by visual estimation in either the main branch (MB) and/or the ostium of the side branch (SB).
Both branches were required to have at least a TIMI flow of II or III, a reference vessel size > 2.25 mm upon visual estimation.
Patients exclusion criteria were myocardial infarction in the 24 hours preceding treatment (STEMI), stenosis of the left main coronary artery unprotected by a graft, cardiogenic shock, angiographic visible thrombus within the target lesion, restenosis or total occlusion of the target lesion, life expectancy < 1 year or suspected intolerance to paclitaxel, aspirin, clopidogrel, ticagrelor or prasugrel.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically driven or ischemia guided target lesion revascularization at 9 months follow up.<br>MACE (for definitions see below) after 9 months<br>• Death<br>• Myocardial infarction (NSTEMI/STEMI)<br>• Stent thrombosis, thrombosis of the target lesion<br>• CABG<br>• TLR<br>• TVR
- Secondary Outcome Measures
Name Time Method Technical aspects<br>• incidence of needed stenting of the main branch<br>• incidende of needed stenting of the side branch<br>• incidence of final kissing<br>• incidence of pure PCI using drug coated balloons without stenting